US FDA Acknowledges API Manufacturers’ GMP Recordkeeping Burden
Executive Summary
Agency acknowledged burden regulations for implementing GMP provisions of FD&C Act placed on API manufacturers in regulatory burden notice.
The US Food and Drug Administration admits that if it expects active pharmaceutical ingredient manufacturers to comply with its good manufacturing practice requirements, it should give them credit for meeting the burden.
The agency has acknowledged the burden regulations for implementing GMP provisions of the Food, Drug and Cosmetic Act place on API manufacturers in a regulatory burden notice published on 10 June.
The oversight in previous annual regulatory burden notices could have been linked to API manufacturers not being subject to the FDA regulations – 21 CFR part 211 – that define GMP compliance for drug product manufacturers and that are routinely cited in drug GMP inspection reports and warning letters.
However, the agency deems APIs adulterated under section 501(a)(2)(B) of the Food, Drug & Cosmetic Act, even though the provision lacks implementing regulations, if it finds failures to conform with current good manufacturing practices as required by the section.
The agency routinely inspects API firms and cites them in inspection reports and warning letters for such failures. (Also see "First-Time OTC Facility Inspections Drove US FDA Warning Letter Surge In FY 2019" - HBW Insight, 6 Nov, 2019.)
As the FDA acknowledged in regulatory burden notice: “to demonstrate that their products comply with the requirements of section 501(a)(2)(B), API manufacturers must maintain CGMP records; therefore, we have counted them among respondents who incur burden for the information collection.”
The agency added 1,260 API manufacturers to the burden notice and estimated that those firms’ staffs would spend nearly 265,000 hours on GMP recordkeeping for 322,560 records prepared.
It says its estimate “reflects burden we attribute to activities associated with recordkeeping requirements found in applicable regulations” and in recommendations in agency guidances including establishing and maintaining standard operating procedures; consulting outside experts; documenting equipment cleaning and maintenance; and compiling and maintaining master production, control and distribution records.
The information in this article was included in an article previously published by Informa Pharma Intelligence's Pink Sheet newsletter.